The Improving Effect of Autologous Stromal Vascular Fraction (SVF) in Adipose Tissue on Skin Grafting

Phase 1

• Conditions: Skin; Deformity, Due to Scar
• Interventions: Biological: stromal vascular fraction; Drug: saline

• Registration Number: NCT02546882
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

Brief Summary

The purpose of this study is to observe whether the transplantation of autologous stromal vascular fraction (SVF) in adipose tissue is safe and its effect on improving the texture and contracture of skin grafting.

Detailed Description

Reconstruction of large scale skin defect is still a challenge for clinical surgeons. The application of skin grafting works as an important choice, however, the strong contracture and poor appearance limit its wide application in scar repair. The stromal vascular fraction (SVF) of adipose tissue is a group of heterogeneous cells including multipotential mesenchymal cells, preadipocytes, endothelial cells, fibroblasts, macrophages and smooth muscle cells. Previous researches have reported that SVF could secrete various angiogenic growth factors in vitro and enhance neovascularisation of ischaemic tissue in vivo. The Adipose-derived Stem cells in the SVF are multipotential stem cells which have the ability to regenerate, while differentiating to become adipose tissue and help to improve the texture of the grafted skin. Besides, SVF is easy to be harvested in large numbers with less donor injury and can be used directly after isolation without in vitro culture, which makes it a good alternative for regenerative medicine.This study is to observe the effect of autologous SVF on improving the texture and contracture of skin grafting.

Patients requiring skin graft of 2 symmetry parts of the body between the age of 3 and 70 years will be enrolled and randomized into two groups, named as the experimental group with SVF transplantation and the control group with no cell transplantation. Patients from the experimental group will have a fat aspiration on the surgery day. The adipose tissue in abdomen or thigh will be digested at 37 °C for 60 min with 0.2% collagenase IV. After filtration and centrifugation, mature adipocytes are separated from the cell pellet. The pellet then is treated with erythrocyte lysis buffer twice to remove red cell fragment. The harvested pellet is SVF. The SVF will be resuspended in saline and transplanted between the grafted skin and the wound with 1 million cells for 1 cm2 area. Skin thickness, texture, contracture and colour will be observed to measure the effect of SVF on skin grafting post treatment.

Study Timeline

• Study First Submitted: 2014-01-23
• Study Start: 2015-02
• Status Verified: 2015-09
• Study First Submitted QC: 2015-09-09
• Last Update Submitted: 2015-09-09
• Study First Posted: 2015-09-11
• Last Update Posted: 2015-09-11
• Primary Completion: 2016-06
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• With symmetrical scar or soft tissue deficiencies requiring skin graft therapy.
• Age of 3 to 70.
• Have no underlying disease except skin scar deformity.
• Have enough healthy donor site skin for both sides of receiving area.

Exclusion Criteria

• Not fit for skin graft treatment;
• Evidence of infection, ischemia, ulcer or other pathological changes within the targeting area which defined as not suitable for skin grafting; or history of delayed healing, radiational therapy;
• Significant renal, cardiovascular, hepatic and psychiatric diseases;
• Significant medical diseases or infection (including but not limited to the carrier of hepatitis B virus or HIV);
• BMI >30;
• Alcohol abuse
• History of any hematological disease, including leukopenia , thrombocytopenia, or thrombocytosis;
• Evidence of malignant diseases or unwillingness to participate.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
stromal vascular fraction	stromal vascular fraction	The adipose tissue in abdomen or thigh will be harvested and digested at 37 °C for 60 min with 0.2% collagenase I/Ⅲ. After filtration and centrifugation, mature adipocytes are separated from the cell pellet. The pellet then is treated with erythrocyte lysis buffer twice to remove red cell fragment. The harvested pellet is stromal vascular fraction (SVF).
saline	saline	1 ml saline without cells will be used as placebo.

Primary Outcome Measures

Name	Time	Method
Measure the texture and colour change of the skin using Cutometer® dual MPA 580 and questionnaires in 6 months post the treatment.	6 months post the treatment.	Questionnaires scores satisfaction range from 0(not satisfied with the result) to 10(good result)

Secondary Outcome Measures

Name	Time	Method
Occurence of major adverse events	Up to approximately 18 months after study start	Including skin graft ischaemia, necrosis, infection, and all other adverse events

Trial Locations

Locations (1)

Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China